Last reviewed · How we verify
Abilify generic
About Abilify
Abilify (aripiprazole) — originally marketed by Generic (originally Otsuka/BMS). Class: Third-generation antipsychotic (D2 partial agonist). First approved 2002-11-15.
Approved generic versions (17)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Aristada | Alkermes Inc | marketed | 2015-01-01 | |
| Aripiprazole Augmentation | Centre for Addiction and Mental Health | marketed | ||
| Aripiprazole or other oral antipsychotics | Otsuka Pharmaceutical Development & Commercialization, Inc. | marketed | ||
| Aripiprazole; Quetiapine | Taichung Veterans General Hospital | marketed | ||
| Aripiprazole tablet | All India Institute of Medical Sciences, Bhubaneswar | marketed | ||
| aripiprazole long acting injectable formulation | Vanguard Research Group | marketed | ||
| Aripiprazole/Escitalopram combination | Massachusetts General Hospital | marketed | ||
| Aripiprazole or Perphenazine | Johns Hopkins University | marketed | ||
| Aripiprazole Once-Monthly | Matt Byerly | marketed | ||
| aripiprazole, quetiapine, or risperidone | Northwell Health | marketed | ||
| Aripiprazole depot | UMC Utrecht | marketed | ||
| Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone | Korea Otsuka Pharmaceutical Co., Ltd. | marketed | ||
| Aripiprazole 6-week group | Seoul National University Hospital | marketed | ||
| Aripiprazole + desvenlafaxine succinate sustained release | Pfizer | marketed | ||
| Aripiprazole 8-week group | Seoul National University Hospital | marketed | ||
| ARIPiprazole 30 MG | Ain Shams University | marketed | ||
| aripiprazole (Abilify) | Massachusetts General Hospital | marketed |
Originator patent timeline
Active patents (20)
- —
11701352· Formulation · US - —
11331315· Formulation · US - —
11648347· Formulation · US - —
10525057· Method of Use · US - —
9268909· Formulation · US - —
11344547· Method of Use · US - —
11154553· Method of Use · US - —
10980803· Method of Use · US - —
11400087· Method of Use · US - —
9694008· Formulation · US - —
11638757· Formulation · US - —
10517951· Formulation · US
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.